BR112016021726B1 - CATHETER STRUCTURES TO REDUCE THE USE OF FLUOROSCOPY DURING ENDOVASCULAR PROCEDURES - Google Patents

Abstract

catheter structures to reduce the use of fluoroscopy during endovascular procedures. The present invention relates to a catheter structure, such as a balloon catheter, guidewire, or the like, with perceptible markings outside the vascularization for use in determining at a location external to the body the position of the catheter structure with respect to a treatment area. Related methods and kits are also revealed.

Description

[001] This application claims priority to Provisional Patent Application Nos. Serial 61/972,580, filed March 31, 2014, and 62/083,745, filed November 24, 2014, the disclosures which are incorporated herein by reference.

technical field

[002] This disclosure generally refers to interventional medical procedures such as angioplasty, and more particularly to a catheter structure with markings to reduce the use of fluoroscopy during the procedure.

background

[003] A physician performing an endovascular procedure such as angioplasty will typically use fluoroscopy in performing a diagnostic angiogram to assess the location of an area of treatment (such as where a lesion or blockage is present in the vasculature). Upon gaining guidewire access to vascularity using additional fluoroscopy and then inserting the catheter with the guidewire, the clinician will then typically use more uniform fluoroscopy, both continuously and intermittently (e.g. spot check to confirm that the catheter has reached the location of the treatment area. As can be seen, this conventional approach increases the exposure of the patient and others, including the physician and assistants, to fluoroscopy and thus the radiation that is generally desired to be avoided for the most part. possible extension.

[004] Certainly, there is a need for a way in which to position a catheter structure to vascularization in a treatment area while reducing the amount or frequency of fluoroscopy used.

summary

[005] One purpose of the disclosure is to provide a catheter structure, such as a catheter balloon, guidewire, or the like, with perceptible markings outside the vascularization for use in determining at a location external to the body the position of the catheter structure in relation to to a treatment area.

[006] A modality refers to an apparatus for use by a physician in the treatment of vascularization. The apparatus may include a catheter structure having a shaft including a first distal portion adapted for positioning in the treatment area and a proximal portion including a physician-perceivable marking external to the vascularization without using fluoroscopy, the marking being representative of a length of one predetermined starting point on the catheter structure. Consequently, the markings can be used to position the catheter structure at a distance in the vascularization corresponding to the length with minimal use of fluoroscopy.

[007] The marking may comprise a plurality of regularly spaced marks or irregularly spaced marks. In one aspect, the marking may be imprinted on the structure of the catheter. The markings may comprise a plurality of first marks and at least one second mark other than the plurality of first marks. For example, the first marks may comprise spaced bands and the second mark may comprise numerical indicia. The marking may be provided adjacent a hub associated with the catheter structure. In an additional aspect, the marking may be luminescent, such as chemiluminescent or photoluminescent.

[008] In a further aspect, the catheter structure may comprise a balloon adjacent to a tip including the predetermined starting point. One or more radiopaque markings may be adjacent to the balloon.

[009] The catheter structure may include a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a focused force wire, or any combination thereof. Additionally, the catheter structure may comprise a guidewire, and may be adapted to slidably receive the guidewire.

[0010] In another embodiment, an apparatus for treating a treatment area at an intravascular location in a body is disclosed. The apparatus may include a catheter including a shaft having a distal portion including a balloon and a proximal portion including at least one marking arranged to be displayed at a reference point external to the body to identify a distance from the treatment area to the reference point. The balloon may further include a treatment element selected from the group consisting of a stent, a graft, a cutter, a focused force wire, or any combination thereof.

[0011] Another modality refers to a method for treating a treatment area on a body. The method may comprise inserting a distal portion of a guidewire into the treatment area, determining a position of a first marking on a proximal portion of the guidewire relative to a reference point, and inserting a catheter a distance corresponding to the first marking.

[0012] An additional modality refers to an apparatus for use by a physician in treating vascularization. The apparatus may include a catheter structure having an axis including a first distal portion adapted for positioning in the treatment area and a proximal portion, and means external to vascularization for determining a length from a predetermined starting point on the catheter structure by which the Determination means can be used to position the catheter structure at a distance in the vascularization corresponding to the length with minimal use of fluoroscopy.

[0013] Another embodiment comprises a catheter including a ruler. An additional embodiment comprises a guidewire including a ruler. A catheter comprising a ruler may be provided and/or used in combination with a guidewire comprising a ruler.

[0014] In another embodiment, a crossed catheter is provided including a plurality of markings to determine an insertion distance into a patient's vascularization. The plurality of markings may comprise a ruler.

[0015] An additional embodiment relates to a method of forming a catheter structure. The method may comprise providing a physician-perceivable marking on a first portion of the catheter structure external to the vascularization to provide a representation of how much a second portion of the catheter structure has been inserted into the vascularization. The delivery step may comprise printing the marking onto the catheter structure. The step of providing may further comprise providing a plurality of first marks and at least one second mark other than the plurality of first marks. The first marks may comprise spaced bands and the second mark may comprise numerical indicia. In one aspect, the amount represents a total distance that a second portion of the catheter structure has been inserted into the vasculature from a reference point external to the vasculature.

[0016] Any of the catheters and/or guidewires disclosed herein may be supplied together in a kit for a treatment of a treatment area in a patient's vasculature. For example, a modality refers to a kit for treating a treatment area in vascularization. The kit may include a first crossover catheter having a first axis including a first distal portion adapted for positioning in or near the treatment area and a first proximal portion including a first marking at a first location, and a second catheter having a second axis including a second distal portion adapted for positioning in the treatment area and a second proximal portion including a second marking at a second location substantially corresponding to a first location of the first marking. The crossover catheter may be adapted to penetrate into or through an occlusion in the treatment area.

[0017] An additional modality includes a kit to treat a treatment area in the vascularization. The kit may comprise a first crossover catheter having a first axis including a first distal portion adapted for positioning in or near the treatment area and a first proximal portion including a first marking at a first location corresponding to a first margin of the treatment area and a second marking at a second location corresponding to a second edge of the treatment area, as well as a second catheter having a second axis including a second distal portion adapted for positioning in the treatment area and a second proximal portion including a third marking on a third location substantially corresponding to the first location or the second location on the first crossover catheter. The second catheter may further include a fourth marking on the second proximal portion at a fourth location corresponding to either the first location or the second location on the first crossover catheter. The second catheter may further include a technology selected from the group consisting of an antrectomy technology, a thrombectomy technology, a PTA technology, a stent technology, and any combination of the above.

[0018] In addition, a method for treating a treatment area on a body is revealed. The method may include inserting a crossover catheter into at least a proximal portion of the treatment area, determining a position of a first marker on the crossover catheter, and inserting a second catheter at least a distance corresponding to the first marker. The method may further include the steps of, after the determining step, inserting the crossover catheter into a distal portion of the treatment area and determining a position of a second marking on the crossover catheter. The step of inserting the crossover catheter into the distal portion of the treatment area may comprise passing the crossover catheter through an occlusion. In one aspect, the crossover catheter may be adapted to penetrate an occlusion or occlusion in the treatment area. The crossover catheter can be adapted to apply energy to penetrate the occlusion or occlusion. For example, the crossover catheter may comprise a cutter, a vibrator, a light source, a fluid source, a nozzle, a rigid or tapered distal tip, or any combination of the foregoing.

[0019] An additional modality refers to a kit to treat a treatment area in a patient's vasculature. The kit of this embodiment may comprise a first crossover catheter having a first axis including a first distal portion adapted for positioning in or near the treatment area and a first proximal portion including a first marking at a first location and a second catheter having a second axis including a second distal portion adapted for positioning in the treatment area and a second proximal portion including a second marking at a second location substantially corresponding to a first location of the first marking. Each of the first label and the second label can be visible external to the patient's body without using fluoroscopy. In one aspect, the second distal portion of the second catheter comprises a balloon. The second catheter may comprise a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a focused force wire, or any combination thereof. In addition, the crossover catheter may be adapted to penetrate into or through an occlusion in the treatment area.

[0020] Another embodiment relates to a kit for treating a treatment area in vascularization, comprising a first crossover catheter having a first axis including a first distal portion adapted for positioning in or near the treatment area and a first proximal portion including a first marking at a first location corresponding to a first edge of the treatment area and a second marking at a second location corresponding to a second edge of the treatment area and a second catheter having a second axis including a second distal portion adapted for positioning in the area and a second proximal portion including a third marking at a third location substantially corresponding to the first location or the second location on the first crossover catheter. The second catheter may further include a fourth marking on the second portion proximal to a fourth location corresponding to either the first location or the second location on the first crossover catheter. In one aspect, the second catheter may include a technology selected from the group consisting of an antrectomy technology, a thrombectomy technology, a PTA technology, a stent technology, and any combination of the foregoing. In any of the above embodiments, the crossover catheter may be adapted to penetrate within an occlusion or occlusion in the treatment area. The crossover catheter may be adapted to apply energy to penetrate within an occlusion or occlusion. In a further aspect, the crossover catheter comprises a cutter, a vibrator, a light source, a fluid source, a nozzle, a rigid or tapered distal tip, or any combination of the foregoing.

[0021] In yet an additional embodiment, a kit is disclosed to treat a treatment area in a patient's vascularization. The kit of such additional embodiment may comprise a first crossover catheter having a first axis including a first distal portion adapted for positioning in the treatment area and a first proximal portion including a plurality of first physician-perceivable markings external to the vascularization without using fluoroscopy, each of which a plurality of first markings being representative of a length of a predetermined first starting point on the first crossover catheter, and a second catheter having a second axis including a second distal portion adapted for positioning in the treatment area and a second proximal portion including a plurality of second ones physician-perceivable markings external to vascularization without using fluoroscopy, each of the plurality of second markings being representative of a length of a predetermined second threshold of the second catheter, wherein a distance between the predetermined first threshold and c Each of the first markers corresponds to a distance between the second predetermined starting point and each of the second markers.

[0022] In this modality, the plurality of first markings can be spaced at regular intervals between them. Each of the first and second axis may further include alphanumeric markings corresponding to each of the first and second markings. At least one of the first or second labels can be chemiluminescent or photoluminescent. In one aspect, at least one of the first or second indentations comprises spaced bands.

[0023] The second catheter may comprise a balloon adjacent a tip including the second predetermined threshold. In addition, a radiopaque marker may be adjacent to the balloon.

[0024] In another embodiment, a kit for treating a treatment area in a patient's vasculature is disclosed. The kit comprises a first crossover catheter having a first shaft including a first distal portion adapted for positioning in the treatment area and a first proximal portion including a first ruler therein. The first ruler may be perceptible by the physician external to the vascularization without using fluoroscopy to measure a distance from a first predetermined starting point on the first crossed catheter. A second catheter having a second axis including a second distal portion adapted for positioning in the treatment area and a second proximal portion including a second ruler therein. The second ruler is still perceptible by the physician external to the vascularization without using fluoroscopy to measure a distance from a second predetermined starting point of the second catheter.

[0025] A further embodiment relates to a kit for treating a treatment area in a patient's vascularization comprising a first crossed catheter having a first axis including first means for measuring a plurality of first distances from a predetermined first point on the first axis , and a second catheter having a second axis including second means for measuring a plurality of second distances from a second predetermined point on the second axis, wherein the first measuring means and second measuring means are perceivable by the physician external to the vascularization without using fluoroscopy (and may, for example, be non-radiopaque in nature), and wherein each of the plurality of first distances corresponds to at least one of the plurality of second distances. The second catheter may comprise a balloon adjacent a distal end of the second axis, and wherein the second predetermined point may be an end of the balloon. The second catheter may further comprise a radiopaque marker adjacent to the balloon.

[0026] An additional modality is a kit to treat a treatment area in a patient's vascularization. The kit comprises a guidewire having a first distal portion adapted for positioning in or near the treatment area and a first proximal portion including a plurality of first physician-perceivable markings external to the vascularization without using fluoroscopy, each of the plurality of first markings being representative of a length of a predetermined first starting point on the catheter and a catheter having an axis including the second distal portion adapted for positioning in the treatment area and a second proximal portion including a plurality of second physician-perceivable markings external to the vascularization without use fluoroscopy, each of the plurality of second markings being representative of a length of a second predetermined threshold of the second catheter, wherein a distance between the first predetermined threshold and each of the first markings corresponds to a distance between the second predetermined threshold finished and each of the second markings.

[0027] The catheter may comprise a balloon. In one aspect, the balloon may be located at a distal end of the catheter, and the second predetermined starting point may be located at a proximal end or a distal end of the balloon. In addition, a radiopaque marker may be adjacent to the balloon.

[0028] The kit may further be provided so that the catheter comprises a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a focused force wire, or any combination thereof. The catheter may include a technology selected from the group consisting of an antrectomy technology, a thrombectomy technology, a PTA technology, a stent technology, and any combination of the above.

[0029] In one aspect, the plurality of first markings are spaced at regular intervals from each other.

[0030] The guidewire and catheter may further include alphanumeric markings corresponding to each of the first and second markings. At least one of the first or second labels can be chemiluminescent or photoluminescent. In another aspect, at least one of the first or second indentations may comprise spaced bands.

[0031] As disclosed in another embodiment, a kit for treating a treatment area in a patient's vascularization comprises a guidewire including a first distal portion adapted for positioning in the treatment area and a first proximal portion including a first ruler therein . The first ruler is perceptible by the physician external to the vascularization without using fluoroscopy and may be non-radiopaque. The first ruler may be adapted to measure a distance from a predetermined first starting point on the guidewire and a catheter having an axis including a second distal portion adapted for positioning in the treatment area and a second proximal portion including a second ruler therein. The second ruler can be perceived by the physician external to the vascularization without using fluoroscopy, for example, being non-radiopaque. The second ruler may be adapted to measure a distance from a second predetermined starting point of the catheter.

[0032] Another additional modality refers to a kit for treating a treatment area in a patient's vascularization. The kit comprises a guidewire including first means for measuring a plurality of first distances from a first predetermined point on the guidewire and a catheter including second means for measuring a plurality of second distances from a second predetermined point on the catheter. The first means for measuring and the second means for measuring may be non-radiopaque in nature and are perceptible to the physician external to the vascularization without using fluoroscopy. Each of the plurality of first distances may correspond to (e.g., equal to) at least one of the plurality of second distances. The catheter may comprise a balloon adjacent a distal end of the catheter and the second predetermined point may be an end of the balloon. The catheter may further comprise a radiopaque marker adjacent to the balloon.

[0033] In another embodiment, a device for treating a treatment area in a patient's vasculature is disclosed, said device comprising a crossed catheter having an axis including a distal portion adapted for positioning in or near the treatment area and a portion proximal including a plurality of markings, said markings being visible external to the patient's body without using fluoroscopy.

[0034] In one aspect, the plurality of markings may comprise a first marking at a first location corresponding to a first edge of the treatment area and a second marking at a second location corresponding to a second edge of the treatment area.

[0035] In another aspect, each of the plurality of markings may be representative of at least a known length from a predetermined starting point on the crossover catheter. These pluralities of markings may be spaced at regular intervals from each other. The axis may additionally include alphanumeric markings corresponding to each of the plurality of markings.

[0036] In any of the above embodiments, at least one of the markings may be chemiluminescent or photoluminescent. Furthermore, at least one of the markings may comprise a spaced strip.

[0037] In a further embodiment, a device for treating a treatment area in a patient's vasculature is disclosed, said device comprising a crossover catheter having an axis including a distal portion adapted for positioning in the treatment area and a proximal portion including a ruler therein, said ruler being perceivable by the physician external to the vascularization without using fluoroscopy to measure a distance from a predetermined starting point on the crossed catheter.

[0038] In any of the above embodiments, the crossover catheter may be adapted to penetrate into or through an occlusion in the treatment area.

[0039] In any of the above modalities, a label perceptible by the clinician external to the vascularization without using fluoroscopy may be a non-radiopaque label.

Brief description of drawings

[0040] Figure 1 is a perspective view of a catheter and balloon according to an embodiment disclosed herein.

[0041] Figure 2 is a cross-section of the balloon of Figure 1 along line 2-2.

[0042] Figure 3 is a further perspective of the catheter and balloon according to an embodiment disclosed herein.

[0043] Figure 4 is an elevational view of a catheter and guidewire according to an additional embodiment disclosed herein.

[0044] Figure 5 and Figure 6 show details of a catheter structure in accordance with an embodiment of the present disclosure.

[0045] Figure 7 shows details of a catheter structure in accordance with a further embodiment of the present disclosure.

[0046] Figure 8 shows a way of using a catheter structure in accordance with an embodiment of the present disclosure.

[0047] Figure 9 shows details of a catheter structure in the form of a guidewire in accordance with another aspect of the disclosure.

[0048] Fig. 10 and Fig. 11 show a way of using the guide wire of Fig. 9 according to an embodiment of the present disclosure.

[0049] Figure 12, Figure 13 and Figure 14 show a way of using a marked crossed catheter in combination with another catheter according to an additional embodiment.

Detailed Description

[0050] The description provided below and in relation to the figures applies to all modes unless otherwise noted and features common to each mode are shown and enumerated similarly.

[0051] A catheter structure is provided in the form of a tubular catheter 10 capable of being actuated to provide a treatment. In this example for purposes of illustration, the catheter 10 includes a distal portion 11 with an actuatable element in the form of a balloon 12 mounted on a catheter tube 14. Referring to Figures 1, 2, and 3, the balloon 12 has a section intermediate 16, or "barrel" having working surface W, and end sections 18, 20. In one embodiment, the end sections 18, 20 reduce in diameter to join the intermediate section 16 to the catheter tube 14 (and thus , sections 18, 20 are generally called cones or cone sections). Balloon 12 is sealed to catheter tube 14 at the ends of the balloon (proximal 15a and distal 15b) at end sections 18, 20 to allow inflation of balloon 12 through one or more inflation lumens 17 that extend within the tube catheter 14 and communicate with the interior of the balloon 12.

[0052] The catheter tube 14 further includes an elongated tubular shaft 24 that forms a lumen 23 that directs another catheter structure, such as a guidewire 26, through the catheter 10. As illustrated in Figure 3, this guidewire 26 may be inserted through a first port 25 of a connector 27, like a hub, into the lumen 23 to achieve an "over the wire" (OTW) arrangement, but could still be supplied in a "quick change" configuration in the which guidewire 26 enters the lumen through a side opening 14a closer to the distal end (see Figure 4). A second port 29 may further be associated with catheter 10, as a connector 27, to introduce fluid (e.g., saline, a contrast agent, or both) into balloon 12 through inflation lumen 17.

[0053] Balloon 12 may include a single-layer or multi-layer balloon wall 28. Balloon 12 may be a non-conforming balloon having a balloon wall 28 that maintains its size and shape in one or more directions when the balloon is inflated. The balloon 12 in that case still has a predetermined surface area that remains constant during and after inflation, still has a predetermined length and predetermined circumference that each, or together, remain constant during and after inflation. However, the balloon 12 could be semi-conforming or conforming, depending on the specific use. The catheter 10 may further be adapted for use in connection with the solution of chronic total occlusions or arthrectomy, and thus may be provided with a cutter or cutting element. The catheter 10 may also be used in connection with a drug, a sharp, a stent, a graft, or similar treatment.

[0054] In order to provide improved localization capability during an interventional procedure by reducing the use of fluoroscopy, the catheter 10 may be provided with a perceptible marking 30 along a portion external to the vascularization during the procedure, such as in or along tube 14. As shown in Figure 5, marking 30 may comprise a plurality of spaced marks 32, such as circular or partially circular bands (e.g., 1 to 359 degrees) around axis 14 and positioned at predetermined intervals. These marks 32 may extend adjacent from connector 27 to the proximal end 15a of balloon 12, or any portion thereof (which is considered the "proximal portion" of catheter 10, in contrast to the distal portion including balloon 12).

[0055] Marks 32 may be evenly or non-uniformly spaced (e.g. marks may be progressively closer together along the length of axis 24). The marks 32 can be of a single color, for example black as shown in figure 5, but as shown in figure 6 they can still be provided in different shades or colors. The marks 32 may further comprise rows of gradations identified by numbers, letters or symbols and thus may effectively form a ruler. In any case, the tags 32 may be non-radiopaque or otherwise may not be fluorescence-adapted.

[0056] The label 30 may further comprise a biocompatible chemiluminescent or photoluminescent material that can be easily visualized in the low light conditions often present during a procedure involving fluoroscopy. Alternatively or additionally, the marking 30 may be provided in a way that allows for tactile perception, as in the form of indentations, bumps, ridges, recesses, or similar structures that can be counted even when not directly visible. In any case, the marking 30 can be incorporated directly into the material of the tube 14 or placed therein (including possibly using printing techniques).

[0057] A further embodiment is shown in Figure 7. In that embodiment, it can be understood that the marking 30 is provided on the catheter 10 in the form of spaced marks 32, each representing a known distance from a predetermined fixed location on the catheter 10. In this illustrated example, the fixed location is the distal tip P, which can be considered the starting point S in terms of the measured distance (but the starting point S could be located anywhere on a structure connected to the catheter 10, such as the distal end of balloon 15b, along the body of balloon 12, or at the proximal end of balloon 15a, as non-limiting examples). Each mark 32 can then represent a fixed distance from the start point S, such as mark 32 at point D indicating a distance of 20 centimeters (which is simply an exemplary value). The point D+1 represents an additional distance, such as 21 centimeters, in a known increment (which could be centimeters, but could still be millimeters, meters, inches, feet, etc. or portions thereof - particular units are not considered important ). Marks 32 can be provided up to a predetermined endpoint E, such as D+75 of starting point S, which in this case represents 95 centimeters (but again, this can be any value depending on desired scale, catheter length, procedure, etc.) .

[0058] Optionally, the catheter 10 may further be provided with one or more secondary markings 34 in the form of printed indicia representing distance, such as in the form of alphanumeric characters. For example, between marking D+10 and marking D+11 in the illustrated embodiment, the number "30" can be printed on the axis as an indication of the distance from the zero point Z, which here is thirty centimeters (but again it is simply a example). This allows the clinician to assess the value for adjacent marks 32 quickly, even when provided in a form that does not admit to be perceptible as a particular distance (eg, a band). The use of characters (e.g. X = 10 cm, L = 50, C=100) is still possible to determine the distance, as is the use of a key in connection with it (e.g. A=10 cm, B =50 cm, C=100 cm).

[0059] In use, and with reference to Figure 8, a catheter 100 including marking 30 may be inserted into a container V in a particular treatment area A, which is shown to comprise a lesion L, but may take other forms ( (e.g., chronic total occlusion, or a location where delivery of a stent, graft, or the like is desired). This can be done following an assessment of the location of the treatment area, such as performing a diagnostic angiogram. Inserting the catheter 100 may involve visualizing the pass marks 32 during insertion through the introducer I and counting them or stopping the insertion process when a known distance is obtained. At the point where marking 30 (as marking 32') corresponds to the intended distance of insertion, the clinician is certified that treatment area A has been obtained by distal portion of catheter 10 (especially when tip P reflects starting point S, in what is the known lesion length L and the known length of balloon 12 or other treatment can be used to achieve correct positioning using simple math). Radiopaque markers, such as strips 102, may optionally be provided to help confirm location using fluoroscopy, use that has otherwise been minimized as a result of using marker 30 to position catheter 100.

[0060] An alternative aspect of the disclosure is to provide a catheter structure in the form of a guidewire 200 with a marking 230, which may be along a portion external to the body during the procedure. As shown in Figure 9, the marking 230 may comprise a plurality of spaced marks 232, such as bands. Such marks 232 may extend adjacent a distal end 200a of guidewire 200 at a proximal end 200b, or any portion thereof.

[0061] Marks 232 may be evenly or non-uniformly spaced (e.g. marks may progressively approach along the length of guidewire 200). The marks 232 may be a single color, such as black, or may be provided in different shades or colors. The marks 232 may further comprise rows of gradations identified by numbers, letters, or symbols, and thus may effectively form a ruler. Markings 232 may be non-radiopaque or may otherwise not be visible under fluoroscopy.

[0062] The 230 label may further comprise a chemiluminescent or photoluminescent biocompatible material that can be readily seen in the low light conditions often present during a procedure involving fluoroscopy. Alternatively or additionally, the marking 230 may be provided in a form that allows tactile engagement, as in the form of notches, bumps, ridges, recesses, or similar structures that can be counted even when not directly visible. In either case, the marking 230 may be incorporated into the guidewire material 200 or placed thereon (including possibly using printing techniques).

[0063] Each mark 232 can then represent a fixed distance from the start point S, such as mark 232 at point B indicating a distance of 20 centimeters (which is simply an exemplary value). The point D+1 represents an additional distance, such as 21 centimeters, in a known increment (which could be centimeters, but could still be millimeters, meters, inches, feet, etc. or any divisions thereof - the specific units are not considered important ). The marks 232 can be provided up to a predetermined point D+75 from the starting point S, which in this case represents a distance of 95 centimeters (but again, this can be any value depending on the desired scale, catheter length, procedure, etc.).

[0064] In use, with reference to Figure 10, a guidewire 200 including marking 230 may be inserted into a container V at a particular location, such as adjacent to a treatment area A. This may include a lesion L, as per shown, but as noted above it can take other forms (eg a chronic total occlusion). Prior to insertion, an assessment of the location of the treatment area, such as performing a diagnostic angiogram, can be completed.

[0065] Inserting the guidewire 200 may involve viewing the through marks 232 during insertion through the introducer I, and counting them or stopping the insertion process when a known distance is obtained (note references S as starting point, D as a first mark, and E as the end point mark). At the point where marking 230 (as marking 232') corresponds to the intended insertion distance, the physician is certified that treatment area A has been obtained. In the case where the guidewire 200 at least partially includes radiopaque markers, the location can be shaped using fluoroscopy, the use that was otherwise minimized as a result of using the marker 230 to position the guidewire 200 in the vascularization. .

[0066] With knowledge of the distance to treatment area A then provided by marking 230 on guidewire 200, the clinician can choose an appropriate treatment device such as a catheter (including those examples mentioned here; see catheter 100 in figure 11 ) having a suitable length. Marking 230 may further be used in positioning catheter 100 in treatment area A using markers 232 to determine insertion distance, such as with respect to a reference point F on guidewire 200, and thus potentially further reduce amount of fluoroscopy required.

[0067] The technology disclosed here can be applied to various types of catheters without limitation. For example, it can still be applied to guide catheters, diagnostic catheters, IVUS catheters, OCT catheters, as well as all crossed or thrombectomy catheters (including those using mechanics (e.g. rigid tips, cutters, etc.), laser, fluid, or vibration energy to penetrate through blockages or occlusions). In one particular example, and with reference to Figure 12, such a crossover catheter 300 may be used to gain access to a desired treatment area A, such as by penetrating through an occlusion O.

[0068] Using the marking 330 comprising marks 332 (which may be the same shape as marks 32 or 232) in connection with such a crossover catheter 300, the physician may notice a first mark (such as mark M) on the catheter 300 (as external to vascularization) corresponding to the catheter insertion distance at the proximal end or X margin of the treatment area A (which may be in relation to an external structure, such as a point on a sheath, introducer I, or similar). Once the crossover catheter 300 is inserted at the end of the treatment area A, as at the distal end or Y edge of the Occlusion O (see Figure 13), a second mark 332 (as the N-mark) on the crossover catheter 300 can be seen. . The first and second marks M, N together then define the length of the treatment area A, and can be measured external to the vasculature to develop the treatment plan or otherwise.

[0069] Subsequently, a second catheter 400 with a marking 430 comprising corresponding or combined markings 432 (such as, for example, a catheter including antrectomy technology (e.g., any orbital, rotational, laser, and directional devices), thrombectomy technology, PTA technology, stent technology, or any other technology) can be inserted the precise distance necessary to place the corresponding catheter portion 400 to deliver the particular treatment at a location corresponding to the treatment area A. This can be obtained by noting the relative location of the corresponding marks (such as M, N, which as noted above may be color coded, specially arranged or formed, identified by an alphanumeric indicator (as to form a ruler)) or otherwise indicated to correspond to the marks 332 in the crossover catheter 300). In the illustrated embodiment, the technology is a PTA technology including treatment T in the form of an inflatable balloon and an associated guidewire 200 that passes through the opening in the occlusion O formed using the crossover catheter 300, but as noted could take other forms.

[0070] As should be noted, this process can be done repeatedly using different types of catheters for different uses, but having corresponding marking technology, all without the prolonged use of fluoroscopy, in order to determine if treatment area A has been obtained. and the associated time involvement. The overall length of the procedure can be reduced, which is especially beneficial, as patients requiring more severe interventions (eg, CTOs) are often the least able to tolerate long-term procedures.

[0071] As can be further noted, the crossover catheter 300 and the second catheter 400 can be supplied as a kit. This arrangement would help the physician ensure that the marks are precisely matched, which can certainly be done during the manufacturing process.

[0072] While the disclosure presents certain modalities to illustrate the inventive concepts, various modifications, alterations and changes to the described modalities are possible without departing the sphere and scope as defined in the appended claims. For example, any ranges and numerical values given in the various modalities are subject to variation due to tolerances, due to variations in environmental factors and material quality, and due to modifications of the balloon structure and shape, and thus can be considered approximate and the The term "approximately" means that the relevant amount may, at a minimum, vary because of these factors. Furthermore, the drawings, while illustrating the inventive concepts, are not scaled and should not be limited to any size or dimension. Of course, it is intended that the present disclosure not be limited to the embodiments described, but have the full scope defined by the language of the following claims, and equivalents thereof.

Claims (4)

1. Kit for treating a treatment area in a vascularization of a patient, said kit comprising: a guidewire (26, 200) including a first distal portion (11) adapted for positioning in the treatment area and a first proximal portion including a first ruler therein, said first ruler being perceivable by the physician external to the vascularization without using fluoroscopy, said first ruler adapted to measure a distance from a predetermined first starting point on the guidewire (26, 200); and a catheter (10) having a shaft (24) including a second distal portion (11) adapted for positioning in the treatment area and a second proximal portion including a second ruler therein, said second ruler being perceivable by the physician external to vascularization without using fluoroscopy, said second ruler adapted to measure a distance from a second predetermined starting point on the catheter (10) characterized in that the catheter (10) comprises a balloon (12) adjacent to a distal end of the catheter (10), and wherein the second predetermined point is an end of the balloon (12). 2. Kit, according to claim 1, characterized in that the catheter (10) further comprises a radiopaque marker adjacent to the balloon (12). 3. Kit according to claim 1 or 2, characterized in that the catheter (10) comprises a treatment element selected from the group consisting of a drug, a stent, a graft, a cutter, a power cord focused, or any combination thereof. 4. Kit according to any one of the preceding claims, characterized in that the catheter (10) includes a technology selected from the group consisting of an antrectomy technology, a thrombectomy technology, a PTA technology, a stent technology , and any combination of the above.

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